The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the regulatory affairs department by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.
This function will involve a thorough understanding of the regulatory requirements required for the Medical Device Industry.
Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required.
Maintains an excellent understanding of the global medical device regulations.
Maintains a thorough understanding of the products assigned to the team.
Works to improve the function of the Regulatory Affairs Department.
Understands the progress of the RA team on assigned tasks, and removes roadblocks.
Provides support to the RA team members to complete assigned tasks.
Mentors and trains new RA team members.
Highlights any updates to regulatory requirements to regulatory management.
Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and updates same on approval status in target markets.
Ensures the biocompatibility requirements of the product are adequately addressed.
Ensures the clinical requirements of the product are adequately addressed.
Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
Provides support to currently marketed products as necessary including input on change requests, etc.
Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
Qualifications / Requirements:
Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required.
Knowledge of requirements in other jurisdictions where required.
Knowledge of medical device quality standards/practises or similar regulated industry.
Good communication and inter-personal skills.
Proven problem-solving skills.
Good computer skills including knowledge of Microsoft® Office.
Proven organisational skills.
Approved External Auditor.
Willingness and availability to travel on company business.
Internal Number: 4385
About Cook Medical - Limerick, Ireland
Cook Medical has been in Limerick since 1993, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support, and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 800 people and manufactures 10 percent of Cook’s products for global markets.